title: Clinical risk factors of PEGylated liposomal doxorubicin induced palmar plantar erythrodysesthesia in recurrent ovarian cancer patients.
abstract: BACKGROUND
  Studies have shown that body composition, age, gender, changes in monocyte count and repeated dosing alter pharmacokinetic properties of PEGylated liposomal doxorubicin (PLD). However, limited information exists regarding the clinical risk factors of ovarian cancer patients who develop palmar plantar erythrodysesthesia (PPE) while receiving PLD for cancer recurrence.
  
  
  METHODS
  We conducted a retrospective cohort analysis of consecutive patients with recurrent ovarian and primary peritoneal cancer who were treated with PLD from 2005 to 2009. Clinical and pathologic data were abstracted from electronic medical records. Statistical analyses were performed using univariate and bivariate analyses, logistic regression, and log rank-tests.
  
  
  RESULTS
  Twenty-three percent (31/133) of patients developed PPE. Age, body mass index (BMI), race, stage, and histology did not significantly differ between PPE and non-PPE patients. There was a possible trend for decreasing PPE with increasing body mass index (BMI) (24.5% of normal weight, 27.5% of overweight; 23.8% of obese class I; 13.3% of obese class II; and 0% of obese class III), though not statistically significant. The number of chemotherapy regimens prior to PLD, and the mean cycles of PLD received did not differ between patients with and without PPE. 77.4% of PPE cases occurred within the first 3 infusion cycles. PPE was not associated with time to progression.
  
  
  CONCLUSIONS
  Nearly one-quarter of ovarian cancer patients receiving PLD will develop PPE. Further investigation of factors such as BMI associated with PPE may aid in patient selection for PLD, and future development of other nanoparticle and liposomal agents.
authors.affiliation: Division of Gynecologic Oncology, University of North Carolina, Chapel Hill, NC, USA. Electronic address: Emily.ko@uphs.upenn.edu.
authors.forename: Emily M
authors.initials: EM
authors.lastname: Ko
authors.forename: Quinn
authors.initials: Q
authors.lastname: Lippmann
authors.forename: Whitney P
authors.initials: WP
authors.lastname: Caron
authors.forename: William
authors.initials: W
authors.lastname: Zamboni
authors.forename: Paola A
authors.initials: PA
authors.lastname: Gehrig
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology*; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000473:pathology; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin
keywords: Doxil; Ovarian cancer; PEGylated liposomal doxorubicin; PPE; Palmar plantar erythrodysesthesia